11/28/2017
https://www.congress.gov...
"REMS has really had two problems with, the first one was we as the generics, as we reverse engineer, need the product that we are reverse engineering to make that."
"And it is using the notion of patient safety to delay the development of additional drugs that could bring down the cost."
"For some medications with serious safety concerns, FDA requires manufacturers to set up risk evaluation and mitigation strategies, otherwise known as REMS programs."
"I support the Honoring Our PACT Act, and I look forward to working with Chairman Tester and Ranking Member Moran to strengthen this legislation so that veterans exposed to toxic substances can get the..."